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NCT01120184 · ClinicalTrials.gov registry record · Phase 3
A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,095
- Enrollment target
NCT01120184: Completed Phase 3 study, sponsored by Hoffmann-La Roche.
NCT01120184 is a Phase 3 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 1,095 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01120184, a Phase 3 study, has completed, sponsored by Hoffmann-La Roche.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,095 participants
- Enrollment target
Study Summary
This randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab (Herceptin) plus taxane (docetaxel or paclitaxel) in participants with HER2-positive progressive or recurrent locally advanced or previously untreated metastatic breast cancer. Participants will be randomized to 1 of 3 treatment arms (Arms A, B or C). Arm A will be open-label, whereas Arms B and C will be blinded.
Primary Outcome
Tumor assessments were performed according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, using radiographic images submitted to the IRF up to and including the confirmatory tumor assessment 4 to 6 weeks after study drug discontinuation. Disease progression was defined as a greater than or equal to (≥) 20 percent (%) and 5-millimeter (mm) increase in sum of diameters of target lesions, taking as reference the smallest sum obtained during the study, or appearance of new les
Interventions
- DRUG docetaxel
- DRUG paclitaxel
- DRUG pertuzumab
- DRUG pertuzumab-placebo
- DRUG trastuzumab [Herceptin]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,095 participants |
| Start Date | 2010-07-31 |
| Est. Completion | 2016-09-16 |
| Phase | Phase 3 |
What the finished NCT01120184 record still lists
NCT01120184 is an interventional study that assigns participants to a tested intervention. Its 1,095 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% higher).
The record links to 0 conditions, and to 5 interventions - of which docetaxel is the first listed.
NCT01120184 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01120184 about?
NCT01120184 is a clinical study titled "A Study of Trastuzumab Emtansine (T-DM1) Plus Pertuzumab/Pertuzumab Placebo Versus Trastuzumab [Herceptin] Plus a Taxane in Participants With Metastatic Breast Cancer (MARIANNE)". This randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab (Herceptin) plus taxane (docetaxel or p...
What is the current status of trial NCT01120184?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,095 participants. The study started on 2010-07-31. Estimated completion is 2016-09-16.
What interventions are being tested in trial NCT01120184?
The interventions under investigation include: docetaxel (DRUG), paclitaxel (DRUG), pertuzumab (DRUG), pertuzumab-placebo (DRUG), trastuzumab [Herceptin] (DRUG).
Who is sponsoring clinical trial NCT01120184?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01120184's enrollment target sits among peer trials
1,095 265th of 2000 higher than 1,735 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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